Biologics

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Special Events

Vendor Presentations

TERMINOLOGY UPDATE(S):

[13-Mar 2009]

Additional units of measure [http://www.fda.gov/oc/datacouncil/splncicodes.html#potency] have been added:
ALLERGY UNITS [AU]
BIOEQUIVALENT ALLERGY UNITS [BAU]
PROTEIN NITROGEN UNITS [PNU]

[01-Sept-2008]
Details on how FDA analyzes Active Ingredients for UNII registration:

• Vaccines: many of the currently approved vaccines have active ingredients already available in UNII list
• Active ingredients for plasma derivatives:
  http://www.fda.gov/oc/datacouncil/1_11_2007SRS_Users_Guide_5B.pdf Chapter 26: Proteins and Peptides
  contains a majority of the relevant characteristics.
• Immune Globulins, Allergenic Extracts: FDA is currently developing a list of relevant characteristics to be included in the SRS

Questions and Answers

SUBTEAM DETAILS

Next meeting: April 2010 [11- 12 EDT]

Minutes

Meeting Date	Minutes
March 25, 2010	BiologicsSubTeam-March2010-Minutes.pdf Details Download 27 KB
May 28, 2009	BiologicsSubTeam-May2009-Minutes.pdf Details Download 29 KB
March 19, 2009	BiologicsSubTeam-Mar2009-Minutes.pdf Details Download 21 KB
January 22, 2009	BiologicsSubTeam-Jan2009-Minutes.pdf Details Download 21 KB
August 21, 2008	BiologicsSubTeam-Aug2008-Minutes.pdf Details Download 33 KB
Sept 25, 2008	BiologicsSubTeam-Sept2008-Minutes.pdf Details Download 23 KB
Nov 17, 2008	BiologicsSubTeam-Nov2008-Minutes.pdf Details Download 31 KB